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Profile for Tradename: TIKOSYN

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Tikosyn is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty patent family members in forty-five countries.

The generic ingredient in TIKOSYN is dofetilide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dofetilide profile page.

Summary for Tradename: TIKOSYN

Suppliers / Packagers: see list9

Pharmacology for Tradename: TIKOSYN

Drug ClassAntiarrhythmic

Clinical Trials for: TIKOSYN

Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block
Status: Completed Condition: Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics

Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults
Status: Completed Condition: Long QT Syndrome

Genetics of QT Prolongation With Antiarrhythmics
Status: Recruiting Condition: Long QT Syndrome; Drug Toxicity

PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide
Status: Not yet recruiting Condition: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
Status: Completed Condition: Drug-induced Surface ECG Changes

High Intensity Focused Ultrasound (HIFU) Ablation System Study
Status: Suspended Condition: Atrial Fibrillation

Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
Status: Completed Condition: Cardiac Arrhythmia; Qt Interval, Variation in

AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
Status: Terminated Condition: Atrial Fibrillation; Heart Failure

Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
Status: Withdrawn Condition: Atrial Fibrillation

A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
Status: Completed Condition: Atrial Fibrillation

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL020931-001Oct 1, 1999RXNo6,124,363<disabled> <disabled>
CAPSULE;ORAL020931-002Oct 1, 1999RXNo6,124,363<disabled> <disabled>
CAPSULE;ORAL020931-003Oct 1, 1999RXYes6,124,363<disabled> <disabled>
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Paragraph IV activity for: TIKOSYN

Drugname Dosage Strength RLD Submissiondate
dofetilideCapsules0.125 mg, 0.25 mg, and 0.5 mgTikosyn5/1/2014

International Patent Family for Tradename: TIKOSYN

Country Document Number Publication Date
Indonesia24658Jul 27, 2000
New Zealand503785Nov 26, 2004
Morocco24683Jul 01, 1999
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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